Mounting structures for components of intravascular devices

ABSTRACT

Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices include at least one mounting structure within a distal portion of the device. In that regard, one or more electronic, optical, and/or electro-optical component is coupled to the mounting structure. In some instances, the mounting structure is formed of a plurality of material layers. In some embodiments, the material layers have substantially constant thicknesses. Methods of making and/or assembling such intravascular devices/systems are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/014,868, filed Aug. 30, 2013, now U.S. Pat. No. 9,974,446,which claims priority to and the benefit of U.S. Provisional PatentApplication No. 61/695,970, filed Aug. 31, 2012, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to intravascular devices, systems, andmethods. In some embodiments, the intravascular devices are guide wiresthat include a mounting structure for one or more sensing components.

BACKGROUND

Heart disease is very serious and often requires emergency operations tosave lives. A main cause of heart disease is the accumulation of plaqueinside the blood vessels, which eventually occludes the blood vessels.Common treatment options available to open up the occluded vesselinclude balloon angioplasty, rotational atherectomy, and intravascularstents. Traditionally, surgeons have relied on X-ray fluoroscopic imagesthat are planar images showing the external shape of the silhouette ofthe lumen of blood vessels to guide treatment. Unfortunately, with X-rayfluoroscopic images, there is a great deal of uncertainty about theexact extent and orientation of the stenosis responsible for theocclusion, making it difficult to find the exact location of thestenosis. In addition, though it is known that restenosis can occur atthe same place, it is difficult to check the condition inside thevessels after surgery with X-ray.

A currently accepted technique for assessing the severity of a stenosisin a blood vessel, including ischemia causing lesions, is fractionalflow reserve (FFR). FFR is a calculation of the ratio of a distalpressure measurement (taken on the distal side of the stenosis) relativeto a proximal pressure measurement (taken on the proximal side of thestenosis). FFR provides an index of stenosis severity that allowsdetermination as to whether the blockage limits blood flow within thevessel to an extent that treatment is required. The normal value of FFRin a healthy vessel is 1.00, while values less than about 0.80 aregenerally deemed significant and require treatment.

Often intravascular catheters and guide wires are utilized to measurethe pressure within the blood vessel, visualize the inner lumen of theblood vessel, and/or otherwise obtain data related to the blood vessel.To date, guide wires containing pressure sensors, imaging elements,and/or other electronic, optical, or electro-optical components havesuffered from reduced performance characteristics compared to standardguide wires that do not contain such components. For example, thehandling performance of previous guide wires containing electroniccomponents have been hampered, in some instances, by the limited spaceavailable for the core wire after accounting for the space needed forthe conductors or communication lines of the electronic component(s),the stiffness and size of the rigid housing containing the electroniccomponent(s), and/or other limitations associated with providing thefunctionality of the electronic components in the limited spaceavailable within a guide wire.

Accordingly, there remains a need for improved intravascular devices,systems, and methods that include a mounting structure for one or moreelectronic, optical, or electro-optical sensing components.

SUMMARY

Embodiments of the present disclosure are directed to intravasculardevices, systems, and methods.

In one embodiment, a guide wire is provided. The guide wire comprises afirst flexible element; a distal core extending within the firstflexible element; a mounting structure fixedly secured to the distalcore, the mounting structure comprising a plurality of material layerssecured to one another, wherein the plurality of material layers definea recess sized and shaped to receive a pressure sensing component; apressure sensing component mounted to the mounting structure; a proximalcore fixedly attached to the mounting structure and extending proximallyfrom the mounting structure; and at least one conductor having aproximal section and a distal section, wherein the distal section of theat least one conductor is coupled to the pressure sensing component andthe proximal section of the at least one conductor is coupled to atleast one connector; wherein the first flexible element and the mountingstructure have an outer diameter of 0.018″ or less.

In another embodiment, a mounting structure for use within a distalportion of a guide wire having an outer diameter of 0.018″ or less isprovided. The mounting structure includes a plurality of material layerssecured to one another, wherein the plurality of material layers definea first recess sized and shaped to receive a pressure sensing componentand a second recess sized and shaped to receive a portion of a core ofthe guide wire.

In some instances, the plurality of material layers of the mountingstructure comprises at least six layers. In some embodiments, theplurality of material layers are each formed of the same material. Inthat regard, in some instances the material is nickel cobalt. Further,in some implementations each of the plurality of material layers has thesame thickness. For example, in some instances the thickness of each ofthe plurality of material layers is between about 0.01 mm and about0.025 mm. In some embodiments, the mounting structure includes aproximal portion, a central portion, and a distal portion. The proximalportion is separated from the central portion by a proximal bridgehaving a reduced outer profile dimension relative to the proximal andcentral portions and the central portion is separated from the distalportion by a distal bridge having a reduced outer profile dimensionrelative to the central and distal portions. In some instances, each ofthe proximal portion, central portion, and distal portion have an outerprofile dimension between about 0.125 mm and about 0.400 mm and each ofthe proximal bridge and the distal bridge have an outer profiledimension between 0.075 mm and about 0.125 mm.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic, schematic side view of an intravascular deviceaccording to an embodiment of the present disclosure.

FIG. 2 is diagrammatic cross-sectional side view of an intravasculardevice according to an embodiment of the present disclosure.

FIG. 3 is a diagrammatic perspective view of a mounting structureaccording to an embodiment of the present disclosure.

FIG. 4 is a diagrammatic proximal end view of the mounting structure ofFIG. 3.

FIG. 5 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 6 is a diagrammatic proximal end view of the mounting structure ofFIG. 5 shown connected to a core according to an embodiment of thepresent disclosure.

FIG. 7 is a diagrammatic partial cross-sectional side view of themounting structure of FIGS. 5 and 6, shown connected to the core.

FIG. 8 is a diagrammatic perspective view of a mounting structureaccording to another embodiment of the present disclosure.

FIG. 9 is a proximal end view of the mounting structure of FIG. 8.

FIG. 10 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 11 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 12 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 13 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 14 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 15 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 16 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 17 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 18 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 19 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 20 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 21 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 22 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

FIG. 23 is a diagrammatic top view of a mounting structure according toanother embodiment of the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

As used herein, “flexible elongate member” or “elongate flexible member”includes at least any thin, long, flexible structure that can beinserted into the vasculature of a patient. While the illustratedembodiments of the “flexible elongate members” of the present disclosurehave a cylindrical profile with a circular cross-sectional profile thatdefines an outer diameter of the flexible elongate member, in otherinstances all or a portion of the flexible elongate members may haveother geometric cross-sectional profiles (e.g., oval, rectangular,square, elliptical, etc.) or non-geometric cross-sectional profiles.Flexible elongate members include, for example, guide wires andcatheters. In that regard, catheters may or may not include a lumenextending along its length for receiving and/or guiding otherinstruments. If the catheter includes a lumen, the lumen may be centeredor offset with respect to the cross-sectional profile of the device.

In most embodiments, the flexible elongate members of the presentdisclosure include one or more electronic, optical, or electro-opticalcomponents. For example, without limitation, a flexible elongate membermay include one or more of the following types of components: a pressuresensor, a temperature sensor, an imaging element, an optical fiber, anultrasound transducer, a reflector, a mirror, a prism, an ablationelement, an RF electrode, a conductor, and/or combinations thereof.Generally, these components are configured to obtain data related to avessel or other portion of the anatomy in which the flexible elongatemember is disposed. Often the components are also configured tocommunicate the data to an external device for processing and/ordisplay. In some aspects, embodiments of the present disclosure includeimaging devices for imaging within the lumen of a vessel, including bothmedical and non-medical applications. However, some embodiments of thepresent disclosure are particularly suited for use in the context ofhuman vasculature. Imaging of the intravascular space, particularly theinterior walls of human vasculature can be accomplished by a number ofdifferent techniques, including ultrasound (often referred to asintravascular ultrasound (“IVUS”) and intracardiac echocardiography(“ICE”)) and optical coherence tomography (“OCT”). In other instances,infrared, thermal, or other imaging modalities are utilized.

The electronic, optical, and/or electro-optical components of thepresent disclosure are often disposed within a distal portion of theflexible elongate member. As used herein, “distal portion” of theflexible elongate member includes any portion of the flexible elongatemember from the mid-point to the distal tip. As flexible elongatemembers can be solid, some embodiments of the present disclosure willinclude a housing portion at the distal portion for receiving theelectronic components. Such housing portions can be tubular structuresattached to the distal portion of the elongate member. Some flexibleelongate members are tubular and have one or more lumens in which theelectronic components can be positioned within the distal portion.

The electronic, optical, and/or electro-optical components and theassociated communication lines are sized and shaped to allow for thediameter of the flexible elongate member to be very small. For example,the outside diameter of the elongate member, such as a guide wire orcatheter, containing one or more electronic, optical, and/orelectro-optical components as described herein are between about 0.0007″(0.0178 mm) and about 0.118″ (3.0 mm), with some particular embodimentshaving outer diameters of approximately 0.014″ (0.3556 mm) andapproximately 0.018″ (0.4572 mm)). As such, the flexible elongatemembers incorporating the electronic, optical, and/or electro-opticalcomponent(s) of the present application are suitable for use in a widevariety of lumens within a human patient besides those that are part orimmediately surround the heart, including veins and arteries of theextremities, renal arteries, blood vessels in and around the brain, andother lumens.

“Connected” and variations thereof as used herein includes directconnections, such as being glued or otherwise fastened directly to, on,within, etc. another element, as well as indirect connections where oneor more elements are disposed between the connected elements.

“Secured” and variations thereof as used herein includes methods bywhich an element is directly secured to another element, such as beingglued or otherwise fastened directly to, on, within, etc. anotherelement, as well as indirect techniques of securing two elementstogether where one or more elements are disposed between the securedelements.

Referring now to FIG. 1, shown therein is a portion of an intravasculardevice 100 according to an embodiment of the present disclosure. In thatregard, the intravascular device 100 includes a flexible elongate member102 having a distal portion 104 adjacent a distal end 105 and a proximalportion 106 adjacent a proximal end 107. A component 108 is positionedwithin the distal portion 104 of the flexible elongate member 102proximal of the distal tip 105. Generally, the component 108 isrepresentative of one or more electronic, optical, or electro-opticalcomponents. In that regard, the component 108 is a pressure sensor, atemperature sensor, an imaging element, an optical fiber, an ultrasoundtransducer, a reflector, a mirror, a prism, an ablation element, an RFelectrode, a conductor, and/or combinations thereof. The specific typeof component or combination of components can be selected based on anintended use of the intravascular device. In some instances, thecomponent 108 is positioned less than 10 cm, less than 5, or less than 3cm from the distal tip 105. In some instances, the component 108 ispositioned within a housing of the flexible elongate member 102. In thatregard, the housing is a separate component secured to the flexibleelongate member 102 in some instances. In other instances, the housingis integrally formed as a part of the flexible elongate member 102.

The intravascular device 100 also includes a connector 110 adjacent theproximal portion 106 of the device. In that regard, the connector 110 isspaced from the proximal end 107 of the flexible elongate member 102 bya distance 112. Generally, the distance 112 is between 0% and 50% of thetotal length of the flexible elongate member 102. While the total lengthof the flexible elongate member can be any length, in some embodimentsthe total length is between about 1300 mm and about 4000 mm, with somespecific embodiments have a length of 1400 mm, 1900 mm, and 3000 mm.Accordingly, in some instances the connector 110 is positioned at theproximal end 107. In other instances, the connector 110 is spaced fromthe proximal end 107. For example, in some instances the connector 110is spaced from the proximal end 107 between about 0 mm and about 1400mm. In some specific embodiments, the connector 110 is spaced from theproximal end by a distance of 0 mm, 300 mm, and 1400 mm.

The connector 110 is configured to facilitate communication between theintravascular device 100 and another device. More specifically, in someembodiments the connector 110 is configured to facilitate communicationof data obtained by the component 108 to another device, such as acomputing device or processor. Accordingly, in some embodiments theconnector 110 is an electrical connector. In such instances, theconnector 110 provides an electrical connection to one or moreelectrical conductors that extend along the length of the flexibleelongate member 102 and are electrically coupled to the component 108.Some specific embodiments of electrical connectors in accordance withthe present disclosure are discussed below in the context of FIGS. 5-11.In other embodiments, the connector 110 is an optical connector. In suchinstances, the connector 110 provides an optical connection to one ormore optical communication pathways (e.g., fiber optic cable) thatextend along the length of the flexible elongate member 102 and areoptically coupled to the component 108. Further, in some embodiments theconnector 110 provides both electrical and optical connections to bothelectrical conductor(s) and optical communication pathway(s) coupled tothe component 108. In that regard, it should again be noted thatcomponent 108 is comprised of a plurality of elements in some instances.In some instances, the connector 110 is configured to provide a physicalconnection to another device, either directly or indirectly. In otherinstances, the connector 110 is configured to facilitate wirelesscommunication between the intravascular device 100 and another device.Generally, any current or future developed wireless protocol(s) may beutilized. In yet other instances, the connector 110 facilitates bothphysical and wireless connection to another device.

As noted above, in some instances the connector 110 provides aconnection between the component 108 of the intravascular device 100 andan external device. Accordingly, in some embodiments one or moreelectrical conductors, one or more optical pathways, and/or combinationsthereof extend along the length of the flexible elongate member 102between the connector 110 and the component 108 to facilitatecommunication between the connector 110 and the component 108.Generally, any number of electrical conductors, optical pathways, and/orcombinations thereof can extend along the length of the flexibleelongate member 102 between the connector 110 and the component 108. Insome instances, between one and ten electrical conductors and/or opticalpathways extend along the length of the flexible elongate member 102between the connector 110 and the component 108. For the sake of clarityand simplicity, the embodiments of the present disclosure describedbelow include three electrical conductors. However, it is understoodthat the total number of communication pathways and/or the number ofelectrical conductors and/or optical pathways is different in otherembodiments. More specifically, the number of communication pathways andthe number of electrical conductors and optical pathways extending alongthe length of the flexible elongate member 102 is determined by thedesired functionality of the component 108 and the correspondingelements that define component 108 to provide such functionality.

Referring now to FIG. 2, shown therein is a cross-sectional side view ofan intravascular device 200 according to an embodiment of the presentdisclosure. As shown, the intravascular device 200 includes a proximalportion 202, a middle portion 204, and a distal portion 206. Generally,the proximal portion 202 is configured to be positioned outside of apatient, while the distal portion 206 and a majority of the middleportion 204 are configured to be inserted into the patient, includingwithin human vasculature. In that regard, the middle and distal portion204 have an outer diameter between about 0.0007″ (0.0178 mm) and about0.118″ (3.0 mm) in some embodiments, with some particular embodimentshaving an outer diameter of approximately 0.014″ (0.3556 mm) orapproximately 0.018″ (0.4572 mm)). In the illustrated embodiment of FIG.2, the intravascular device 200 has an outer diameter of 0.014″ (0.3556mm).

As shown, the distal portion 206 of the intravascular device 200 has adistal tip 207 defined by an element 208. In the illustrated embodiment,the distal tip 207 has a rounded profile. In some instances, the element208 is radiopaque such that the distal tip 207 is identifiable underx-ray, fluoroscopy, and/or other imaging modalities when positionedwithin a patient. In some particular instances, the element 208 issolder secured to a flexible element 210 and/or a flattened tip core212. In that regard, in some instances the flexible element 210 is acoil spring. The flattened tip core 212 extends distally from a distalcore 214. As shown, the distal core 214 tapers to a narrow profile as itextends distally towards the distal tip 207. In some instances, thedistal core 214 is formed of a stainless steel that has been ground downhave the desired tapered profile. In some instances, the distal core 214or at least a portion thereof is flattened to define an atraumatic tipto the intravascular device 200. In some particular instances, thedistal core 214 is formed of high tensile strength 304V stainless steel.In an alternative embodiment, the distal core 214 is formed by wrappinga stainless steel shaping ribbon around a nitinol core. Solder points216 secure the distal core 214 to a mounting structure 218. The mountingstructure 218 is configured to receive and securely hold a component220. In that regard, the component 220 is one or more of an electroniccomponent, an optical component, and/or electro-optical component. Forexample, without limitation, the component 220 may be one or more of thefollowing types of components: a pressure sensor, a temperature sensor,an imaging element, an optical fiber, an ultrasound transducer, areflector, a mirror, a prism, an ablation element, an RF electrode, aconductor, and/or combinations thereof.

The mounting structure 218 is fixedly secured within the distal portion206 of the intravascular device 200. As will be discussed below in thecontext of the exemplary embodiments of FIGS. 3-23, the mountingstructure 218 may be fixedly secured to one or more cores (e.g., asingle core running along the length of the mounting structure; aproximal core; a distal core; both a proximal core and a distal core)and/or a hypotube or other structure surrounding at least a portion ofthe mounting structure. In the illustrated embodiment, the mountingstructure is disposed within flexible element 210 and/or a flexibleelement 224 and secured in place by an adhesive or solder 222. In someinstances, the flexible element 224 is ribbon coil covered with apolymer coating. For example, in one embodiment the flexible element 224is a stainless steel ribbon wire coil coated with polyethyleneterephthalate (PET). In another embodiment, the flexible element is apolyimide tubing that has a ribbon wire coil embedded therein. Forexample, in some instances a polyimide or Pebax tubing with embeddedcoil is utilized for flexible element 224. In some particularembodiments, the ribbon wire coil is embedded to an inner diameter ofthe polyimide tubing. In some instances, an opening is created in thetubing to allow the surrounding ambient pressure to reach apressure-sensing implementation of component 220. Accordingly, in someimplementations the pitch and/or spacing of an embedded ribbon coil hasadequate spacing such that an opening can be created solely through thesurrounding polymer portions of the tubing (i.e., not through the coil)and still provide sufficient access to facilitate accurate pressurereadings. The adhesive 222 is utilized to secure the mounting structure218 to the flexible element 210 and/or the flexible element 224 in someimplementations. Accordingly, in some instances the adhesive is urethaneacrylate, cyanoacrylate, silicone, epoxy, and/or combinations thereof.

The mounting structure 218 is also secured to a core 226 that extendsproximally from the mounting structure towards the middle portion 204 ofthe intravascular device 200. In that regard, a distal portion 228 ofthe core 226 tapers as it extends distally towards mounting structure218. A distal end of the distal portion 228 of the core 226 is fixedlysecured to the mounting structure 218. In some instances, the distal endof the core 226 is soldered to the mounting structure 218. As shown,adhesive 230 surrounds at least a portion of the distal portion 228 ofthe core 226. In some instances, the adhesive 230 is the adhesive 222used to secure the mounting structure 218 to the flexible element 210and/or flexible element 224. In other instances, adhesive 230 is adifferent type of adhesive than adhesive 222. In one particularembodiment, adhesive or solder 222 is particularly suited to secure themounting structure to flexible element 210, while adhesive 230 isparticularly suited to secure the mounting structure to flexible element224.

A communication cable 232 extends along the length of the intravasculardevice 200 from the proximal portion 202 to the distal portion 206. Inthat regard, the distal end of the communication cable 232 is coupled tothe component 220 at junction 234. The type of communication cableutilized is dependent on the type of electronic, optical, and/orelectro-optical components that make up the component 220. In thatregard, the communication cable 232 may include one or more of anelectrical conductor, an optical fiber, and/or combinations thereof.Appropriate connections are utilized at the junction 234 based on thetype of communication lines included within communication cable 232. Forexample, electrical connections are soldered in some instances, whileoptical connections pass through an optical connector in some instances.In some embodiments, the communication cable 232 is a trifilarstructure. Further, it is understood that all and/or portions of each ofthe proximal, middle, and/or distal portions 202, 204, 206 of theintravascular device 200 may have cross-sectional profiles as shown inFIGS. 2-5 of U.S. Provisional Patent Application No. 61/665,697 filed onJun. 28, 2012, which is hereby incorporated by reference in itsentirety.

Further, in some embodiments, the proximal portion 202 and/or the distalportion 206 incorporate spiral ribbon tubing as disclosed in U.S.Provisional Patent Application No. 61/665,697 filed on Jun. 28, 2012. Insome instances, the use of such spiral ribbon tubing allows a furtherincrease in the available lumen space within the device. For example, insome instances use of a spiral ribbon tubing having a wall thicknessbetween about 0.001″ and about 0.002″ facilitates the use of a core wirehaving an outer diameter of at least 0.0095″ within a 0.014″ outerdiameter guide wire using a trifilar with circular cross-sectionalconductor profiles. The size of the core wire can be further increasedto at least 0.010″ by using a trifilar with the flattened oblongcross-section conductor profiles. The availability to use a core wirehaving an increased diameter allows the use of materials having a lowermodulus of elasticity than a standard stainless steel core wire (e.g.,superelastic materials such as Nitinol or NiTiCo are utilized in someinstances) without adversely affecting the handling performance orstructural integrity of the guide wire and, in many instances, providesimprovement to the handling performance of the guide wire, especiallywhen a superelastic material with an increased core diameter (e.g., acore diameter of 0.0075″ or greater) is utilized within the distalportion 206.

The distal portion 206 of the intravascular device 200 also optionallyincludes at least one imaging marker 236. In that regard, the imagingmarker 236 is configured to be identifiable using an external imagingmodality, such as x-ray, fluoroscopy, angiograph, CT scan, MRI, orotherwise, when the distal portion 206 of the intravascular device 200is positioned within a patient. In the illustrated embodiment, theimaging marker 236 is a radiopaque coil positioned around the tapereddistal portion 228 of the core 226. Visualization of the imaging marker236 during a procedure can give the medical personnel an indication ofthe size of a lesion or region of interest within the patient. To thatend, the imaging marker 236 can have a known length (e.g., 0.5 cm or 1.0cm) and/or be spaced from the element 208 by a known distance (e.g., 3.0cm) such that visualization of the imaging marker 236 and/or the element208 along with the anatomical structure allows a user to estimate thesize or length of a region of interest of the anatomical structure. Itis understood that a plurality of imaging markers 236 are utilized insome instances. In that regard, in some instances the imaging markers236 are spaced a known distance from one another to further facilitatemeasuring the size or length of the region of interest.

In some instances, a proximal portion of the core 226 is secured to acore 238 that extends through the middle portion 204 of theintravascular device. In that regard, the transition between the core226 and the core 238 may occur within the distal portion 206, within themiddle portion 204, and/or at the transition between the distal portion206 and the middle portion 204. For example, in the illustratedembodiment the transition between core 226 and core 238 occurs in thevicinity of a transition between the flexible element 224 and a flexibleelement 240. The flexible element 240 in the illustrated embodiment is ahypotube. In some particular instances, the flexible element is astainless steel hypotube. Further, in the illustrated embodiment aportion of the flexible element 240 is covered with a coating 242. Inthat regard, the coating 242 is a hydrophobic coating in some instances.In some embodiments, the coating 242 is a polytetrafluoroethylene (PTFE)coating. In some implementations, the flexible element 240 is configuredto provide more structural support than the flexible element 224. Forexample, in some instances the flexible 240 provides increasedpushability and torqueability. Further, in some instances, primaryfunctions of the flexible element 224 include providing a constant outerdiameter for device delivery and to act as a substrate for lubriciouscoatings (e.g., hydrophilic coatings in some instances). In someinstances, the flexible element 224 provides minimal structural supportand/or torqueability, while the distal core 226 provides the desiredstructural support and torque response for the working section of theintravascular device 200 that enters vasculature.

The proximal portion of core 226 is fixedly secured to the distalportion of core 238. In that regard, any suitable technique for securingthe cores 226, 238 to one another may be used. In some embodiments, atleast one of the cores 226, 238 includes a plunge grind or otherstructural modification that is utilized to couple the cores together.In some instances, the cores 226, 238 are soldered together. In someinstances, an adhesive is utilized to secure the cores 226, 238together. In some embodiments, combinations of structural interfaces,soldering, and/or adhesives are utilized to secure the cores 226, 238together. In other instances, the core 226 is not fixedly secured tocore 238. For example, in some instances, the core 226 and the core 246are fixedly secured to the hypotube 240 and the core 238 is positionedbetween the cores 226 and 246, which maintains the position of the core238 between cores 226 and 246.

In some embodiments, the core 238 is formed of a different material thanthe core 226. For example, in some instances the core 226 is formed ofnitinol and the core 238 is formed of stainless steel. In otherinstances, the core 238 and the core 226 are formed of the samematerial. In some instances the core 238 has a different profile thanthe core 226, such as a larger or smaller diameter and/or a non-circularcross-sectional profile. For example, in some instances the core 238 hasa D-shaped cross-sectional profile. In that regard, a D-shapedcross-sectional profile has some advantages in the context of anintravascular device 200 that includes one or more electronic, optical,or electro-optical component in that it provides a natural space to runany necessary communication cables while providing increased strengththan a full diameter core.

In some instances, a proximal portion of the core 238 is secured to acore 246 that extends through at least a portion of the proximal portion202 of the intravascular device 200. In that regard, the transitionbetween the core 238 and the core 246 may occur within the proximalportion 202, within the middle portion 204, and/or at the transitionbetween the proximal portion 202 and the middle portion 204. Forexample, in the illustrated embodiment the transition between core 238and core 246 is positioned distal of a plurality of conducting bands248. In that regard, in some instances the conductive bands 248 areportions of a hypotube. Proximal portions of the communication cable 232are coupled to the conductive bands 248. In that regard, in someinstances each of the conductive bands is associated with acorresponding communication line of the communication cable 232. Forexample, in embodiments where the communication cable 232 consists of atrifilar, each of the three conductive bands 248 are connected to one ofthe conductors of the trifilar, for example by soldering each of theconductive bands to the respective conductor. Where the communicationcable 232 includes optical communication line(s), the proximal portion202 of the intravascular device 200 includes an optical connector inaddition to or instead of one or more of the conductive bands 248. Aninsulating layer or sleeve 250 separates the conductive bands 248 fromthe core 246. In some instances, the insulating layer 250 is formed ofpolyimide.

As noted above, the proximal portion of core 238 is fixedly secured tothe distal portion of core 246. In that regard, any suitable techniquefor securing the cores 238, 246 to one another may be used. In someembodiments, at least one of the cores includes a structural featurethat is utilized to couple the cores together. In the illustratedembodiment, the core 238 includes an extension 252 that extends around adistal portion of the core 246. In some instances, the cores 238, 246are soldered together. In some instances, an adhesive is utilized tosecure the cores 238, 246 together. In some embodiments, combinations ofstructural interfaces, soldering, and/or adhesives are utilized tosecure the cores 238, 246 together. In other instances, the core 226 isnot fixedly secured to core 238. For example, in some instances and asnoted above, the core 226 and the core 246 are fixedly secured to thehypotube 240 and the core 238 is positioned between the cores 226 and246, which maintains the position of the core 238 between cores 226 and246. In some embodiments, the core 246 is formed of a different materialthan the core 238. For example, in some instances the core 246 is formedof Nitinol and/or NiTiCo (nickel-titanium-cobalt alloy) and the core 238is formed of stainless steel. In that regard, by utilizing a nitinolcore within the conductive bands 248 instead of a stainless steel thelikelihood of kinking is greatly reduced because of the increasedflexibility of the nitinol core compared to a stainless steel core. Inother instances, the core 238 and the core 246 are formed of the samematerial. In some instances the core 238 has a different profile thanthe core 246, such as a larger or smaller diameter and/or a non-circularcross-sectional profile.

Referring now to FIGS. 3-23, shown therein are various embodiments ofmounting structures for use within intravascular devices. In someembodiments, the mounting structures of the present disclosure are sizedand shaped for use within guide wires having a diameter of 0.018″ or0.014″. Referring initially to FIGS. 3 and 4, shown therein is amounting structure 300. As will be discussed below, mounting structure300 is configured for use with a core that extends along the length ofthe mounting structure. Accordingly, in some embodiments where themounting structure 300 is utilized as mounting structure 218 ofintravascular device 200 discussed above, distal core 214 and proximalcore 226 are defined by a single core that extends along and/or throughmounting structure 300.

As shown, mounting structure 300 includes a body 302 having variousstructural features to facilitate interfacing with other components ofthe intravascular device. For example, the body 302 includes a recess304 configured to receive a sensing component of the intravasculardevice. In the illustrated embodiment, the recess 304 is particularlysuited for use with a pressure sensing element. In that regard, therecess 304 includes a portion 306 and a portion 308. Portion 306 has awider profile than portion 308. Accordingly, in some implementationsportion 306 is sized and shaped to receive a main body of a pressuresensing element, while portion 308 is sized and shaped to receive aportion of an active portion of the pressure sensing element (e.g., acantilevered structure including a pressure-sensing diaphragm). In someinstances, the portion 308 is recessed a greater distance relative to anupper surface (as viewed in FIG. 3) of the body 302 than portion 306.Such an arrangement allows the diaphragm or other pressure sensingportion to be positioned face up and/or face down within the recess 308.In other instances, the portions 306 and 308 have the same depthrelative to an upper surface of the body 302. The body 302 also includesa recess 310 proximal of the recess 304 and adjacent a proximal portion312 of the body. In some instances, recess 310 is sized and shaped tofacilitate connection of conductors to a sensing element mounted withinrecess 304. For example, in some implementations conductors of atrifilar are connected to a pressure sensing element seated withinrecess 304 by positioning the conductors within recess 310. The body 302includes a distal portion 314 opposite proximal portion 312 that isconfigured to interface with components of the distal tip of the guidewire, such as a distal core, distal coil, and/or other features.

As best seen in FIG. 4, the body 302 defines a recess or opening 316that extends along the length of the mounting structure 300 between theproximal portion 312 and the distal portion 314. In that regard, therecess or opening 316 is sized and shaped to interface with a core wire.In some instances, the core wire is positioned within the recess/opening316 and then fixedly secured into place using solder, adhesive, and/orother suitable techniques. As also shown in FIG. 4, the body 302 of themounting structure 300 has a maximum height 318 and a maximum width 320.In some embodiments, the maximum height 318 is between about 0.125 mmand about 0.400 mm, with some 0.014″ outer diameter devices having amaximum height of approximately 0.200 mm and some 0.018″ outer diameterdevices having a maximum height of approximately 0.300 mm. In someembodiments, the maximum width 320 is between about 0.28 mm and about0.50 mm, with some 0.014″ outer diameter devices having a maximum widthof approximately 0.295 mm and some 0.018″ outer diameter devices havinga maximum height of approximately 0.450 mm. In the illustratedembodiment, the sides of the mounting structure 300 have an overallrounded or arcuate profile. In that regard, the radius or rate ofcurvature of the rounded/arcuate sides is determined based on thedesired outer diameter (e.g., 0.014″, 0.018″, etc.) of the guide wireinto which the mounting structure 300 will be incorporated. As discussedbelow, the rounded/arcuate shape of the body 302 is defined in step-wisemanner by varying the width of adjacent material layers of a pluralityof layers that make of the body 302 in some instances. As shown in FIG.3, the body 302 also has a length 322 between its proximal and distalends. In some embodiments, the length 322 is between about 1.5 mm andabout 2.2 mm.

As shown in FIG. 4, the body 302 is made up of a plurality of materiallayers. In the illustrated embodiment, the body 302 includes layers 330,331, 332, 333, 334, 335, 336, 337, and 338. Generally, structures inaccordance with the present disclosure may use between two and fiftymaterial layers to define a desired three-dimensional structural layout.However, most structures for use within guide wires having an outerdiameter of 0.014″ will utilize between six and twelve material layers.In that regard, layer 330 defines a bottom surface of the body 302,layer 338 defines an upper surface of the body, and layers 331, 332,333, 334, 335, 336, and 337 are intermediate layers therebetween. In theillustrated embodiment, each of the layers 330, 331, 332, 333, 334, 335,336, 337, and 338 is a plate-like structure (i.e., having parallel upperand lower surfaces with a generally constant thickness). In someembodiments, each layer has thickness (i.e., measured in the directionof height 318 of the body 302 between an upper boundary of the layer anda lower boundary of the layer) between about 0.01 mm and about 0.025 mm.In some embodiments, at least layers 330, 331, 332, 333, 334, 336, 337,and 338 each have a common thickness. Further, while layer 335 isidentified as a single layer having an increased thickness relative tothe other layers 330, 331, 332, 333, 334, 336, 337, and 338 in FIG. 4,it is understood that in some instances layer 335 is comprised of aplurality of layers having the common thickness that are coupledtogether to form the collective layer 335.

By precisely defining the geometry of each layer 330, 331, 332, 333,334, 335, 336, 337, and 338 and then arranging the layers together, theresulting body 302 can define very precise structures. For example, theboundaries of recess 304 can be precisely defined to match those of apressure sensor to be mounted within the recess. In that regard, theillustrated embodiment of FIG. 3 shows a tapered transition consistingof angled surfaces extending between portion 306 of recess 304 andportion 308. In some instances, the tapered transition is defined bylayers 337 and 338, while the surface of portion 306 is defined by layer336. To that end, in some embodiments manufacturing techniques areutilized that allow for micron-level precision in the manufacturing ofeach layer and, therefore, result in micron-level precision in theresulting structure of the body 302. This increased precision of thebody 302 allows for the structural support required to limit thetransfer of external forces (e.g., from curvature of the intravasculardevice passing through a vessel) to the sensing element, which can causeerrors in the resulting measurements of the sensing element, to beachieved through a minimum sized mounting structure. As a result of thereduced size of the mounting structure 300 achievable using the multiplelayer arrangements of the present disclosure, the overall flexibility ofthe distal portion of the intravascular device can be increased, whichleads to better maneuverability and control of the intravascular device.

In some instances, the mounting structure 300 and other mountingstructures of the present application are manufactured using one or moreof the following steps. As an initial step, a structural design for thebody 302 of the mounting structure is created. In that regard, thestructural design of the body 302 takes into account such considerationsas guide wire diameter, sensing element properties (e.g., type, size,shape, communication lines needed, etc.), desired flexibility of theguide wire, core wire interface(s), hypotube characteristics, desiredstiffness of mounting structure, and/or features related to the mountingstructure and/or related components of the guide wire. Based on thestructural design, the body 302 is separated into a plurality ofdiscrete material layers. In that regard, each layer has a definedtwo-dimensional profile based on the overall structural design. Thethickness of each of the plurality of layers is determined based on theoverall structural design. As discussed above, the plurality of layersmay have a common thickness, different thicknesses, and/or combinationsthereof. In some instances, the thickness of each layer is between about5 μm and about 25 μm. With the structural design separated into aplurality of layers, one or more copies of the device are laid out on awafer. Depending on the size of the device, anywhere from tens tohundreds to thousands of device layouts can be placed on a single wafer.Photomasks are produced for each layer in some instances. With the waferlayout established and photomasks ready, a sacrificial layer (e.g.,copper) is electroplated on the wafer (e.g., a ceramic wafer). Asunderstood by those skilled in the art, the sacrificial layer is removed(e.g., etched) at the end of the fabrication process to release thecreated mounting structure from the wafer. With the sacrificial layerdeposited, a precise thickness of photoresist is applied to the wafer.Then the appropriate photomask is placed on top of the photoresist. Inthat regard, it is understood that the mounting structure 300 can beformed by beginning with layer 330 and going to layer 338 or formed bybeginning with layer 338 and going to layer 330. Accordingly, dependingon the order of formation, the appropriate photomask is utilized. Thephotomask is exposed to ultraviolet light to create a pattern on thesurface of the photoresist.

With the pattern formed on the photoresist, the wafer is placed into anelectro-deposition cell or chamber. The electro-deposition cell orchamber causes metal ions to be deposited in accordance with thepattern. In that regard, the metal ions used is dependent on the desiredmetal for the resulting mounting structure. In some instances, the metalis palladium, a Nickel Cobalt alloy (e.g., 80% nickel, 20% cobalt in oneembodiment), and/or other suitable metal. With the metal layerdeposited, the photoresist is removed and the sacrificial material(e.g., copper) is deposited where the photoresist was removed. Thesacrificial material fills any gaps between layers of the body and actsas a stable, electrically conductive structure for the formation of asubsequent layer. The deposited metal and sacrificial layer are thenplanarized to the desired thickness for that layer of the body. Theplanarization process ensures that the layer has the desired thickness,flatness, and parallel surfaces needed for formation of the mountingstructure. In some embodiments, the planarization process controls suchfeatures within 2 microns. The steps of applying a photoresist,patterning using a photomask, depositing metal into the pattern,removing the photoresist, applying a sacrificial material, andplanarizing is repeated for each layer of the body. In that regard, themounting structures of the present disclosure generally have between 6layers and 15 layers, but some embodiments may have a greater number orfewer number of layers. Once all of the layers have been formed, all ofthe sacrificial material is removed to define the resulting device andrelease it from the wafer. In some particular embodiments, the mountingstructures of the present disclosure are manufactured by Microfabrica®having a place of business in Van Nuys, Calif.

Referring now to FIGS. 5-7, shown therein is a mounting structure 350according to another embodiment of the present disclosure. As will bediscussed below, in contrast to mounting structure 300 that isconfigured for use with a core that extends along the length of themounting structure, mounting structure 350 is configured for use withtwo cores, in particular a proximal core extending proximally from themounting structure and a distal core extending distally from themounting structure. Accordingly, in some embodiments where the mountingstructure 350 is utilized as mounting structure 218 of intravasculardevice 200 discussed above, distal core 214 and proximal core 226 arecoupled to the mounting structure 350 distally and proximally,respectively.

As shown, mounting structure 350 includes a body 352 having variousstructural features to facilitate interfacing with other components ofthe intravascular device. For example, the body 352 includes a recess354 configured to receive a sensing component of the intravasculardevice. In the illustrated embodiment, the recess 354 is particularlysuited for use with a pressure sensing element. In that regard, therecess 354 includes a portion 356 and a portion 358. Portion 356 has awider profile than portion 358. Accordingly, in some implementationsportion 356 is sized and shaped to receive a main body of a pressuresensing element, while portion 358 is sized and shaped to receive aportion of an active portion of the pressure sensing element (e.g., acantilevered structure including a pressure-sensing diaphragm). In someinstances, the portion 358 is recessed a greater distance relative to anupper surface (as viewed in FIGS. 5 and 6) of the body 352 than portion356. Such an arrangement allows the diaphragm or other pressure sensingportion to be positioned face up and/or face down within the recess 358.In other instances, the portions 356 and 358 have the same depthrelative to an upper surface of the body 352. The body 352 also includesa recess 360 proximal of the recess 354 and adjacent a proximal portion362 of the body. In some instances, recess 360 is sized and shaped tofacilitate connection of conductors to a sensing element mounted withinrecess 354. For example, in some implementations conductors of atrifilar are connected to a pressure sensing element seated withinrecess 354 by positioning the conductors within and along recess 360.The body 352 includes a distal portion 364 opposite proximal portion 362that is configured to interface with components of the distal tip of theguide wire, such as a distal core, distal coil, and/or other features.

As shown in FIGS. 6 and 7, a proximal core 370 is coupled to theproximal portion 362 of the body 352. In the illustrated embodiment, thecore 372 includes a distal tip 372, a section 374 extending proximallyfrom the distal tip 372 having a reduced diameter or outer profilerelative to the distal tip (as shown in FIG. 7), and a section 376extending proximally from section 374. As shown, section 376 has anincreased diameter or outer profile relative to section 374. In someembodiments, section 376 and distal tip 372 have the same orsubstantially similar diameter or outer profile. In the illustratedembodiment, the core 370 includes tapered transitions between section374 and each of the distal tip 372 and section 376. However, in otherembodiments the transitions are stepped. The core 370 is secured to thebody 302 via recess or opening 378 defined in the proximal portion 362of the mounting structure 350. In that regard, the recess or opening 378extends along the length of the mounting structure 350 distally from theproximal end of the body 352. In some embodiments, the recess or opening378 is arranged such that a core positioned within the recess or opening378 will be coaxially aligned with a central longitudinal axis of themounting structure 350 and/or the guide wire into which the mountingstructure is implemented. In other instances, the recess or opening isarranged such that a core positioned within the recess or opening 378will be offset relative to a central longitudinal axis of the mountingstructure 350 and/or the guide wire into which the mounting structure isimplemented. In the illustrated embodiment, the opening 378 isconfigured such that the core 370 is offset slightly in a downwarddirection relative to a central longitudinal axis of the mountingstructure 350 as view in FIGS. 6 and 7.

As shown in FIG. 7, the recess or opening 378 includes a portion 380 anda portion 382. Portion 382 extends distally from the proximal end of thebody 302 to portion 380. As shown, portion 380 has an increased diameteror outer profile relative to the portion 382. In that regard, the recessor opening 378 and, in particular, the portions 380, 382 are sized andshaped to interface with a core wire. For example, in the illustratedembodiment portion 380 is sized and shaped to interface with the distaltip 372 of the core 370, while portion 382 is sized and shaped to allowthe distal tip 372 to pass therethrough to portion 380 and also tointerface with section 374 of the core once the core is seated withinthe recess or opening 378. In that regard, the core 370 is fixedlysecured into place within the recess or opening 378 using solder 384 insome instances. In that regard, the solder 384 that fills portion 380adheres to the distal tip 372 of the core 370 such that the distal tipand associated solder cannot pass through portion 382 of the recess oropening 378, thereby mechanically and/or chemically securing the core370 to the mounting structure 350. Adhesive(s) and/or other suitabletechniques for securing the core 370 to the body 352 are used in otherinstances. It is understood that the shape, size, and orientation of therecess or opening 378 can be varied to accommodate different types ofcores, including different core shapes, sizes, and materials.Accordingly, for example, the recess or opening 378 may have a constantprofile, one or more step-wise transitions, one or more taperedtransitions, and/or other variations as appropriate. Further, it isunderstood that similar approaches are utilized to connect the distalcore to the distal portion 364 of the body 352.

Generally, the body 352 of the mounting structure 350 has a maximumheight between about 0.125 mm and about 0.400 mm, a maximum widthbetween about 0.28 mm and about 0.50 mm, and a length between about 1.5mm and about 2.2 mm. Further, in the illustrated embodiment, the sidesof the mounting structure 350 have an overall rounded or arcuateprofile, as shown in FIG. 6. In that regard, the radius or rate ofcurvature of the rounded/arcuate sides is determined based on thedesired outer diameter (e.g., 0.014″, 0.018″, etc.) of the guide wireinto which the mounting structure 350 will be incorporated. Therounded/arcuate shape of the body 352 is defined in step-wise manner byvarying the width of adjacent material layers of a plurality of layersthat make of the body 352 in some instances. In that regard, the body352 is made up of a plurality of material layers, as discussed in detailabove with respect to mounting structure 300, in some embodiments.Again, by precisely defining the geometry of each layer and thenarranging the layers together, the resulting body 352 can define veryprecise structures configured to provide structural support andinterface with other components of a guide wire. To that end, in someembodiments manufacturing techniques are utilized that allow formicron-level precision in the manufacturing of each layer (such as thosedescribed above) and, therefore, result in micron-level precision in theresulting structure of the body 352. This increased precision of thebody 352 allows for the structural support required to limit thetransfer of external forces (e.g., from curvature of the intravasculardevice passing through a vessel) to the sensing element, which can causeerrors in the resulting measurements of the sensing element, to beachieved through a minimum sized mounting structure. As a result of thereduced size of the mounting structure 350 achievable using the multiplelayer arrangements of the present disclosure, the overall flexibility ofthe distal portion of the intravascular device can be increased, whichleads to better maneuverability and control of the intravascular device.

Referring now to FIGS. 8 and 9, shown therein is a mounting structure400 according to another embodiment of the present disclosure. As willbe discussed below, mounting structure 400 is configured to interfacewith and be secured to a hypotube, coil, and/or other element that atleast partially surrounds the mounting structure. Accordingly, forexample, in some embodiments where the mounting structure 400 isutilized as mounting structure 218 of intravascular device 200 discussedabove, the mounting structure is secured to flexible element 224 and/orflexible element 210. The mounting structure 400 is also secured to aproximal core and/or distal core in some embodiments.

As shown, mounting structure 400 includes a body 402 having variousstructural features to facilitate interfacing with other components ofthe intravascular device. For example, the body 402 includes a recess404 configured to receive a sensing component of the intravasculardevice. In the illustrated embodiment, the recess 404 is particularlysuited for use with a pressure sensing element. In that regard, therecess 404 includes a portion 406 and a portion 408. Portion 406 has awider profile than portion 408. Accordingly, in some implementationsportion 406 is sized and shaped to receive a main body of a pressuresensing element, while portion 408 is sized and shaped to receive aportion of an active portion of the pressure sensing element (e.g., acantilevered structure including a pressure-sensing diaphragm). In someinstances, the portion 408 is recessed a greater distance relative to anupper surface (as viewed in FIG. 8) of the body 402 than portion 406.Such an arrangement allows the diaphragm or other pressure sensingportion to be positioned face up and/or face down within the recess 408.In other instances, the portions 406 and 408 have the same depthrelative to an upper surface of the body 402. The body 402 also includesrecesses 410, 412, and 414 proximal of the recess 404 and adjacent aproximal portion 316 of the body. As shown in FIG. 8, recess 414 isrecessed a greater distance relative to the upper surface of the body402 than recess 412, while recess 412 is recessed a greater distancerelative to the upper surface of the body 402 than recess 410. In someinstances, recess 414 is sized and shaped to facilitate connection of aproximal core to the body 402. In some instances, recess 412 is sizedand shaped to facilitate passage of a trifilar and/or other type ofcommunication cable from the body 402 to within a lumen of a hypotube orother tubular structural coupled to the proximal portion of the body. Insome instances, recess 410 is sized and shaped to facilitate connectionof conductors to a sensing element mounted within recess 404. Forexample, in some implementations conductors of a trifilar are connectedto a pressure sensing element seated within recess 404 by positioningthe conductors within and along recess 410. The body 402 includes adistal portion 418 opposite proximal portion 416 that is configured tointerface with components of the distal tip of the guide wire, such as adistal core, distal coil, and/or other features.

Generally, the body 402 of the mounting structure 400 has a maximumheight between about 0.125 mm and about 0.400 mm, a maximum widthbetween about 0.28 mm and about 0.50 mm, and a length between about 1.5mm and about 2.2 mm. Further, in the illustrated embodiment, the sidesof the mounting structure 400 have an overall rounded or arcuateprofile, as shown in FIG. 9. In that regard, the radius or rate ofcurvature of the rounded/arcuate sides is determined based on thedesired outer diameter (e.g., 0.014″, 0.018″, etc.) of the guide wireinto which the mounting structure 400 will be incorporated. Therounded/arcuate shape of the body 402 is defined in step-wise manner byvarying the width of adjacent material layers of a plurality of layersthat make of the body 402 in some instances. In that regard, the body402 is made up of a plurality of material layers, as discussed in detailabove with respect to mounting structure 300, in some embodiments.Again, by precisely defining the geometry of each layer and thenarranging the layers together, the resulting body 402 can define veryprecise structures configured to provide structural support andinterface with other components of a guide wire. To that end, in someembodiments manufacturing techniques are utilized that allow formicron-level precision in the manufacturing of each layer (such as thosedescribed above) and, therefore, result in micron-level precision in theresulting structure of the body 402. This increased precision of thebody 402 allows for the structural support required to limit thetransfer of external forces (e.g., from curvature of the intravasculardevice passing through a vessel) to the sensing element, which can causeerrors in the resulting measurements of the sensing element, to beachieved through a minimum sized mounting structure. As a result of thereduced size of the mounting structure 400 achievable using the multiplelayer arrangements of the present disclosure, the overall flexibility ofthe distal portion of the intravascular device can be increased, whichleads to better maneuverability and control of the intravascular device.

Referring now to FIGS. 10-23, shown therein are additional exemplaryembodiments of mounting structures according to present disclosure. Inthat regard, the mounting structures of FIGS. 10-23 incorporate many ofthe features discussed above with respect to mounting structures 300,350, and 400 and may be manufactured using similar techniques.Accordingly, the following discussion focuses on the general structuresof the illustrated embodiments. In that regard, common referencenumerals are used across different embodiments to represent similarstructural features. Further, it should be noted that the mountingstructures illustrated in FIGS. 3-23 are drawn to scale and therefore,the structural arrangements of the mounting structures are to scale.

Referring now to FIG. 10, shown therein is a mounting structure 450according to another embodiment of the present disclosure. As shown,mounting structure 450 includes a body 452 having various structuralfeatures to facilitate interfacing with other components of anintravascular device, such as a guide wire. For example, the body 452includes a recess 454 extending from an upper surface that is configuredto receive a sensing component of the intravascular device. In theillustrated embodiment, the recess 454 is particularly suited for usewith a pressure sensing element. In that regard, the recess 454 includesa portion 456 and a portion 458. Portion 456 has a wider profile thanportion 458. Accordingly, in some implementations portion 456 is sizedand shaped to receive a main body of a pressure sensing element, whileportion 458 is sized and shaped to receive a portion of an activeportion of the pressure sensing element (e.g., a cantilevered structureincluding a pressure-sensing diaphragm). In some instances, the portion458 is recessed a greater distance relative to an upper surface of thebody 452 than portion 456. Such an arrangement allows the diaphragm orother pressure sensing portion to be positioned face up and/or face downwithin the recess 458. In other instances, the portions 456 and 458 havethe same depth relative to an upper surface of the body 452.

The body 452 also includes a recess or opening 460 extending from abottom surface (i.e., opposite of recess 454) that is configured tofacilitate coupling of a core to the body 452. In the illustratedembodiment, the recess or opening 460 extends along the length of themounting structure 450 distally from the proximal end of the body 452.In some embodiments, the recess or opening 460 is arranged such that acore positioned within the recess or opening 460 will be coaxiallyaligned with a central longitudinal axis of the mounting structure 450and/or the guide wire into which the mounting structure is implemented.In other instances, the recess or opening is arranged such that a corepositioned within the recess or opening 460 will be offset relative to acentral longitudinal axis of the mounting structure 450 and/or the guidewire into which the mounting structure is implemented. As shown, therecess or opening 460 includes a portion 462 and a portion 464. Portion462 extends distally from the proximal end of the body 452 to portion464. As shown, portion 464 has an increased diameter or outer profilerelative to the portion 462. In that regard, the recess or opening 460and, in particular, the portions 462, 464 are sized and shaped tointerface with a core wire. For example, in some instances portion 464is sized and shaped to interface with a distal tip of the core, whileportion 462 is sized and shaped to allow the distal tip to passtherethrough to portion 464. In that regard, the core is fixedly securedinto place within the recess or opening 460 using solder, adhesive,and/or other suitable techniques in some instances. Accordingly,proximal portion 466 of the body 452 is configured to interface with thecore and/or other components of the guide wire positioned proximal ofthe sensing element. The body 452 includes a distal portion 468 oppositeproximal portion 466 that is configured to interface with components ofthe distal tip of the guide wire, such as a distal core, distal coil,and/or other features.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 452 of the mounting structure 450 has amaximum height about 0.125 mm and about 0.400 mm, a maximum widthbetween about 0.28 mm and about 0.50 mm, and a length between about 1.5mm and about 2.2 mm, with some particular embodiments having a maximumheight of about 0.2 mm and a maximum width of about 0.295 mm. Thesedimensions can be scaled up or down for larger or smaller diameter guidewires. Further, in the illustrated embodiment, the sides of the mountingstructure 450 have an overall rounded or arcuate profile (not shown, butsee examples with respect to mounting structures 300, 350, and 400above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 450 will be incorporated. The rounded/arcuate shape of thebody 452 is defined in step-wise manner by varying the width of adjacentmaterial layers of a plurality of layers that make of the body 452 insome instances. In that regard, the body 452 is made up of a pluralityof material layers, as discussed in detail above, in some embodiments.

Referring now to FIG. 11, shown therein is a mounting structure 470according to another embodiment of the present disclosure. As shown,mounting structure 470 includes a body 472 having a proximal portion474, a distal portion 476, and various structural features to facilitateinterfacing with other components of an intravascular device, such as aguide wire. For example, the body 472 includes recess 454 havingportions 456 and 458 as described above. The body 472 also includes arecess or opening 460 extending from a bottom surface (i.e., opposite ofrecess 454) that is configured to facilitate coupling of a core to thebody 472 as described above. Accordingly, proximal portion 474 of thebody 472 is configured to interface with the core and/or othercomponents of the guide wire positioned proximal of the sensing element.

The distal portion 476 of the body is configured to interface withcomponents of the distal tip of the guide wire, such as a distal core,distal coil, and/or other features. In the illustrated embodiment, thedistal portion 476 of the body 472 includes a recess or opening 480extending from a bottom surface (i.e., opposite of recess 454) that isconfigured to facilitate coupling of a distal core to the body 472. Asshown, the recess or opening 480 includes a portion 482 and a portion484. Portion 482 extends proximally from the distal end of the body 472to portion 484. As shown, portion 484 has an increased diameter or outerprofile relative to the portion 482. In that regard, the recess oropening 480 and, in particular, the portions 482, 484 are sized andshaped to interface with a core wire. For example, in some instancesportion 484 is sized and shaped to interface with a proximal tip of thecore, while portion 482 is sized and shaped to allow the proximal tip topass therethrough to portion 484. In that regard, the core is fixedlysecured into place within the recess or opening 480 using solder,adhesive, and/or other suitable techniques in some instances.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 472 of the mounting structure 470 has amaximum height about 0.125 mm and about 0.400 mm, a maximum widthbetween about 0.28 mm and about 0.50 mm, and a length between about 1.5mm and about 2.2 mm, with some particular embodiments having a maximumheight of about 0.2 mm and a maximum width of about 0.295 mm. Thesedimensions can be scaled up or down for larger or smaller diameter guidewires. Further, in the illustrated embodiment, the sides of the mountingstructure 470 have an overall rounded or arcuate profile (not shown, butsee examples with respect to mounting structures 300, 350, and 400above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 470 will be incorporated. The rounded/arcuate shape of thebody 472 is defined in step-wise manner by varying the width of adjacentmaterial layers of a plurality of layers that make of the body 472 insome instances. In that regard, the body 472 is made up of a pluralityof material layers, as discussed in detail above, in some embodiments.

Referring now to FIG. 12, shown therein is a mounting structure 490according to another embodiment of the present disclosure. In thatregard, mounting structure 490 is similar to mounting structure 450 ofFIG. 10 in many respects. However, mounting structure 490 includes threebody portions separated by narrower bridges or links, instead of asingle body structure. In particular, mounting structure 490 includes acentral body 492, a proximal body 494 adjacent a proximal portion 496,and a distal body 498 adjacent a distal portion 500. The central body492 includes recess 454 extending from an upper surface that isconfigured to receive a sensing component of the intravascular device.Further, proximal body 494 includes a recess or opening 460 extendingfrom a bottom surface (i.e., opposite of recess 454) that is configuredto facilitate coupling of a core to the mounting structure 490. Furtherstill, the distal body 498 is configured to interface with components ofthe distal tip of the guide wire, such as a distal core, distal coil,and/or other features.

As shown, the proximal body 494 is connected to the central body 492 bya bridge 502, while the distal body 498 is connected to the central body492 by a bridge 504. As shown, the bridges 502, 504 have a reducedprofile relative to the proximal, central, and distal bodies 494, 492,and 496. In that regard, in some implementations the bridges 502, 504are defined by a fewer number of material layers than the proximal,central, and distal bodies 494, 492, and 496. In some embodiments, thebridges 502, 504 have an outer diameter or other outer profile (e.g.,for other geometric and non-geometric cross-sectional profiles)approximately the size of a core wire used within the intravasculardevice. Accordingly, in some embodiments, the bridges 502, 504 have anouter diameter or other outer profile between about 0.075 mm and about0.125 mm. Further, in some embodiments the bridges 502, 504 have alength along the longitudinal axis of the mounting structure 490 betweenabout 0.1 mm and about 0.5 mm. It should be noted that while bridges502, 504 are shown as having substantially similar structural profiles,in other embodiments that outer profiles and/or lengths of the bridges502, 504 are different. In some embodiments, the bridges 502, 504 areintegrally formed with the proximal, central, and distal bodies 494,492, and 496. In other embodiments, the bridges 502, 504 are formedseparately and fixedly attached to the proximal, central, and distalbodies 494, 492, and 496.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 490 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 0.16 mm and about2.7 mm, with one particular embodiment having a maximum height of about0.225 mm, a maximum width of about 0.295 mm, and a length of about 1.8mm. These dimensions can be scaled up or down for larger or smallerdiameter guide wires. Further, in the illustrated embodiment, the sidesof the mounting structure 490 have an overall rounded or arcuate profile(not shown, but see examples with respect to mounting structures 300,350, and 400 above). In that regard, the radius or rate of curvature ofthe rounded/arcuate sides is determined based on the desired outerdiameter (e.g., 0.014″, 0.018″, etc.) of the guide wire into which themounting structure 490 will be incorporated.

Referring now to FIG. 13, shown therein is a mounting structure 510according to another embodiment of the present disclosure. In thatregard, mounting structure 510 is similar to mounting structure 470 ofFIG. 11 in many respects. However, mounting structure 510 includes threebody portions separated by narrower bridges or links, instead of asingle body structure. In particular, mounting structure 510 includes acentral body 512, a proximal body 514 adjacent a proximal portion 516,and a distal body 518 adjacent a distal portion 520. The central body512 includes recess 454 extending from an upper surface that isconfigured to receive a sensing component of the intravascular device.Further, proximal body 514 includes a recess or opening 460 extendingfrom a bottom surface (i.e., opposite of recess 454) that is configuredto facilitate coupling of a core to the mounting structure 510. Furtherstill, the distal body 518 is configured to interface with components ofthe distal tip of the guide wire, such as a distal core, distal coil,and/or other features, and includes a recess or opening 480 extendingfrom the bottom surface (i.e., opposite of recess 454). As shown, theproximal body 514 is connected to the central body 512 by a bridge 502,while the distal body 518 is connected to the central body 512 by abridge 504.

In some embodiments, the bridges 502, 504 have an outer diameter orother outer profile (e.g., for other geometric and non-geometriccross-sectional profiles) approximately the size of a core wire usedwithin the intravascular device. Accordingly, in some embodiments, thebridges 502, 504 have an outer diameter or other outer profile between0.075 mm and about 0.125 mm. Further, in some embodiments the bridges502, 504 have a length along the longitudinal axis of the mountingstructure between about 0.1 mm and about 0.5 mm. In that regard, thebridges 502, 504 of FIGS. 12 and 13 have a length of about 0.175 mm,whereas FIG. 14 illustrates a mounting structure 530 substantiallysimilar to mounting structure 510, but with bridges 532, 534 having anincreased length of about 0.5 mm. It should be noted that while bridges502, 504 are shown as having substantially similar structural profiles,in other embodiments that outer profiles and/or lengths of the bridges502, 504 are different. In some embodiments, the bridges 502, 504 areintegrally formed with the proximal, central, and distal bodies 494,492, and 496 (e.g., using a fewer number of material layers). In otherembodiments, the bridges 502, 504 are formed separately and fixedlyattached to the proximal, central, and distal bodies 494, 492, and 496.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 510 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 0.16 mm and about2.7 mm, with one particular embodiment having a maximum height of about0.225 mm, a maximum width of about 0.295 mm, and a length of about 2.45mm. These dimensions can be scaled up or down for larger or smallerdiameter guide wires. Further, in the illustrated embodiment, the sidesof the mounting structure 510 have an overall rounded or arcuate profile(not shown, but see examples with respect to mounting structures 300,350, and 400 above). In that regard, the radius or rate of curvature ofthe rounded/arcuate sides is determined based on the desired outerdiameter (e.g., 0.014″, 0.018″, etc.) of the guide wire into which themounting structure 510 will be incorporated.

Referring now to FIG. 15, shown therein is a mounting structure 550according to another embodiment of the present disclosure. As shown,mounting structure 550 includes a body 552, having a proximal portion554 and a distal portion 556, that includes various structural featuresto facilitate interfacing with other components of an intravasculardevice, such as a guide wire. For example, the body 552 includes recess454 extending from an upper surface that is configured to receive asensing component of the intravascular device. The body 552 alsoincludes a recess or opening 560 extending from a bottom surface (i.e.,opposite of recess 454) that is configured to facilitate coupling of acore to the body 552. In the illustrated embodiment, the recess oropening 560 extends along the length of the mounting structure 550distally from the proximal end of the body 552. In some embodiments, therecess or opening 560 is arranged such that the majority of a corepositioned within the recess or opening 560 will be coaxially alignedwith a central longitudinal axis of the mounting structure 550 and/orthe guide wire into which the mounting structure is implemented. Inother instances, the recess or opening is arranged such that a corepositioned within the recess or opening 560 will be offset relative to acentral longitudinal axis of the mounting structure 550 and/or the guidewire into which the mounting structure is implemented. As shown, therecess or opening 560 includes proximal and distal portions 562 and 564that are generally aligned with one another and a central portion 566positioned between and offset relative to the proximal and distalportions 562, 564. In that regard, the central portion 566 is incommunication with the proximal and distal portion 562, 564. As shown,portion 562 extends distally from the proximal end of the body 552 toportion 566, which continues distally to portion 564. The recess oropening 560 and, in particular, the portions 562, 564, and 566 are sizedand shaped to interface with a core wire. In some instances the recessor opening 560 is sized and shaped to interface with a distal tip of aproximal core. In that regard, the core is fixedly secured into placewithin the recess or opening 560 using solder, adhesive, and/or othersuitable techniques in some instances. In that regard, the offset ofcentral portion 566 provides a mechanical locking feature with respectto the solder, adhesive, and/or other suitable bonding technique in someinstances. Further, in some instances the transitions between theproximal and distal portions 562, 564 create one or more bend(s) in thedistal tip of the core to further facilitate mechanical coupling betweenthe core and the mounting structure 550. In that regard, the illustratedslot design provides not only locking capability from a tensile force,but the jogged shape also ensures a good torsional force transmission.Accordingly, proximal portion 554 of the body 552 is configured tointerface with the core and/or other components of the guide wirepositioned proximal of the sensing element. The distal portion 556 ofthe body 552 is configured to interface with components of the distaltip of the guide wire, such as a distal core, distal coil, and/or otherfeatures.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 552 of the mounting structure 550 has amaximum height between about 0.125 mm and about 0.400 mm, a maximumwidth between about 0.28 mm and about 0.50 mm, and a length betweenabout 1.5 mm and about 2.2 mm, with some particular embodiments having amaximum height of about 0.2 mm and a maximum width of about 0.295 mm.These dimensions can be scaled up or down for larger or smaller diameterguide wires. Further, in the illustrated embodiment, the sides of themounting structure 550 have an overall rounded or arcuate profile (notshown, but see examples with respect to mounting structures 300, 350,and 400 above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 550 will be incorporated. The rounded/arcuate shape of thebody 552 is defined in step-wise manner by varying the width of adjacentmaterial layers of a plurality of layers that make of the body 552 insome instances. In that regard, the body 552 is made up of a pluralityof material layers, as discussed in detail above, in some embodiments.

Referring now to FIG. 16, shown therein is a mounting structure 570according to another embodiment of the present disclosure. As shown,mounting structure 570 includes a body 572 having a proximal portion574, a distal portion 576, and various structural features to facilitateinterfacing with other components of an intravascular device, such as aguide wire. For example, the body 572 includes recess 454 havingportions 456 and 458 as described above. The body 572 also includes arecess or opening 560 extending from a bottom surface (i.e., opposite ofrecess 454) that is configured to facilitate coupling of a core to thebody 572 as described above. Accordingly, proximal portion 574 of thebody 572 is configured to interface with the core and/or othercomponents of the guide wire positioned proximal of the sensing element.The distal portion 576 of the body is configured to interface withcomponents of the distal tip of the guide wire, such as a distal core,distal coil, and/or other features. In the illustrated embodiment, thedistal portion 576 of the body 572 includes a recess or opening 480extending from a bottom surface (i.e., opposite of recess 454) that isconfigured to facilitate coupling of a distal core to the body 572.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 572 of the mounting structure 570 has amaximum height between about 0.125 mm and about 0.400 mm, a maximumwidth between about 0.28 mm and about 0.50 mm, and a length betweenabout 1.5 mm and about 2.2 mm, with some particular embodiments having amaximum height of about 0.2 mm and a maximum width of about 0.295 mm.These dimensions can be scaled up or down for larger or smaller diameterguide wires. Further, in the illustrated embodiment, the sides of themounting structure 570 have an overall rounded or arcuate profile (notshown, but see examples with respect to mounting structures 300, 350,and 400 above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 450 will be incorporated. The rounded/arcuate shape of thebody 572 is defined in step-wise manner by varying the width of adjacentmaterial layers of a plurality of layers that make of the body 572 insome instances. In that regard, the body 572 is made up of a pluralityof material layers, as discussed in detail above, in some embodiments.

Referring now to FIG. 17, shown therein is a mounting structure 590according to another embodiment of the present disclosure. In thatregard, mounting structure 590 is similar to mounting structure 550 ofFIG. 15 in many respects. However, mounting structure 590 includes threebody portions separated by narrower bridges or links, instead of asingle body structure. In particular, mounting structure 590 includes acentral body 592, a proximal body 594 adjacent a proximal portion 596,and a distal body 598 adjacent a distal portion 600. The central body592 includes recess 454 extending from an upper surface that isconfigured to receive a sensing component of the intravascular device.Further, proximal body 594 includes a recess or opening 560 extendingfrom a bottom surface (i.e., opposite of recess 454) that is configuredto facilitate coupling of a core to the mounting structure 590. Furtherstill, the distal body 598 is configured to interface with components ofthe distal tip of the guide wire, such as a distal core, distal coil,and/or other features. As shown, the proximal body 594 is connected tothe central body 592 by a bridge 502, while the distal body 598 isconnected to the central body 592 by a bridge 504.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 590 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 0.16 mm and about2.7 mm, with one particular embodiment having a maximum height of about0.225 mm, a maximum width of about 0.295 mm, and a length of about 1.8mm. These dimensions can be scaled up or down for larger or smallerdiameter guide wires. Further, in the illustrated embodiment, the sidesof the mounting structure 590 have an overall rounded or arcuate profile(not shown, but see examples with respect to mounting structures 300,350, and 400 above). In that regard, the radius or rate of curvature ofthe rounded/arcuate sides is determined based on the desired outerdiameter (e.g., 0.014″, 0.018″, etc.) of the guide wire into which themounting structure 590 will be incorporated.

Referring now to FIG. 18, shown therein is a mounting structure 610according to another embodiment of the present disclosure. In thatregard, mounting structure 610 is similar to mounting structure 570 ofFIG. 16 in many respects. However, mounting structure 610 includes threebody portions separated by narrower bridges or links, instead of asingle body structure. In particular, mounting structure 610 includes acentral body 612, a proximal body 614 adjacent a proximal portion 616,and a distal body 618 adjacent a distal portion 620. The central body612 includes recess 454 extending from an upper surface that isconfigured to receive a sensing component of the intravascular device.Further, proximal body 614 includes a recess or opening 560 extendingfrom a bottom surface (i.e., opposite of recess 454) that is configuredto facilitate coupling of a core to the mounting structure 610. Furtherstill, the distal body 618 is configured to interface with components ofthe distal tip of the guide wire, such as a distal core, distal coil,and/or other features, and includes a recess or opening 480 extendingfrom the bottom surface (i.e., opposite of recess 454). As shown, theproximal body 614 is connected to the central body 612 by a bridge 502,while the distal body 618 is connected to the central body 612 by abridge 504.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 610 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 0.16 mm and about2.7 mm, with one particular embodiment having a maximum height of about0.225 mm, a maximum width of about 0.295 mm, and a length of about 1.8mm. These dimensions can be scaled up or down for larger or smallerdiameter guide wires. Further, in the illustrated embodiment, the sidesof the mounting structure 610 have an overall rounded or arcuate profile(not shown, but see examples with respect to mounting structures 300,350, and 400 above). In that regard, the radius or rate of curvature ofthe rounded/arcuate sides is determined based on the desired outerdiameter (e.g., 0.014″, 0.018″, etc.) of the guide wire into which themounting structure 610 will be incorporated.

Referring now to FIGS. 19-23, shown therein are mounting structuresaccording to additional embodiments of the present disclosure. In thatregard, the embodiments of FIGS. 19-23 are similar in many respects tothe embodiments of FIGS. 10, 11, 13, 15, and 16, respectively, butinclude an alternative recess design for interfacing with a sensingcomponent compared to recess 454 discussed above. For example, referringmore specifically to FIG. 19, shown therein is a mounting structure 630that includes a body 632 having various structural features tofacilitate interfacing with other components of an intravascular device,such as a guide wire. For example, the body 632 includes a recess 634extending from an upper surface that is configured to receive a sensingcomponent of the intravascular device. In the illustrated embodiment,the recess 634 is particularly suited for use with a pressure sensingelement. In that regard, the recess 634 includes a planar surfaceportion 636 sized and shaped to receive a body of a pressure sensingelement. Further, in the illustrated embodiment the body 632 includes anopening 638 extending through the body from an upper surface to a lowersurface. In some instances, a diaphragm and/or other pressure sensitiveportion of a pressure sensing element mounted within recess 634 is influid communication with the opening 638. In some particularembodiments, the diaphragm and/or other pressure sensitive portion ofthe pressure sensing element is positioned directly over the opening 638(either face down (i.e., diaphragm or other pressure sensitive portiontowards the opening 638) or face up (i.e., diaphragm or other pressuresensitive portion away from the opening 638)) when mounted. As shown,the body 632 includes a recess or opening 460 adjacent a proximalportion 640. The recess or opening 460 extends from a bottom surface(i.e., opposite of recess 634) that is configured to facilitate couplingof a core to the body 632. The body 632 also includes a distal portion642 opposite proximal portion 640 that is configured to interface withcomponents of the distal tip of the guide wire, such as a distal core,distal coil, and/or other features.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 632 of the mounting structure 630 has amaximum height between about 0.125 mm and about 0.400 mm, a maximumwidth between about 0.28 mm and about 0.50 mm, and a length betweenabout 1.5 mm and about 2.2 mm, with some particular embodiments having amaximum height of about 0.2 mm and a maximum width of about 0.295 mm.These dimensions can be scaled up or down for larger or smaller diameterguide wires. Further, in the illustrated embodiment, the sides of themounting structure 630 have an overall rounded or arcuate profile (notshown, but see examples with respect to mounting structures 300, 350,and 400 above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 630 will be incorporated.

Referring now to FIG. 20, shown therein is a mounting structure 650according to another embodiment of the present disclosure. As shown,mounting structure 650 includes a body 652 having a proximal portion654, a distal portion 656, and various structural features to facilitateinterfacing with other components of an intravascular device, such as aguide wire. For example, the body 652 includes recess 634 and opening638 as described above. The body 652 also includes a recess or opening460 extending from a bottom surface (i.e., opposite of recess 634) thatis configured to facilitate coupling of a core to the body 652. Thedistal portion 656 of the body is configured to interface withcomponents of the distal tip of the guide wire, such as a distal core,distal coil, and/or other features. In the illustrated embodiment, thedistal portion 656 of the body 652 includes a recess or opening 480extending from a bottom surface (i.e., opposite of recess 634) that isconfigured to facilitate coupling of a distal core to the body 472.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the body 652 of the mounting structure 650 has amaximum height between about 0.125 mm and about 0.400 mm, a maximumwidth between about 0.28 mm and about 0.50 mm, and a length betweenabout 1.5 mm and about 2.2 mm, with some particular embodiments having amaximum height of about 0.2 mm and a maximum width of about 0.295 mm.These dimensions can be scaled up or down for larger or smaller diameterguide wires. Further, in the illustrated embodiment, the sides of themounting structure 650 have an overall rounded or arcuate profile (notshown, but see examples with respect to mounting structures 300, 350,and 400 above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 650 will be incorporated.

Referring now to FIG. 21, shown therein is a mounting structure 660according to another embodiment of the present disclosure. As shown,mounting structure 660 includes a central body 662, a proximal body 664adjacent a proximal portion 666, and a distal body 668 adjacent a distalportion 670, and various structural features to facilitate interfacingwith other components of an intravascular device, such as a guide wire.For example, the central body 662 includes recess 634 and opening 638.The proximal body 664 includes a recess or opening 460 extending from abottom surface (i.e., opposite of recess 634) that is configured tofacilitate coupling of a core to the mounting structure 660. The distalbody 668 includes a recess or opening 480 extending from a bottomsurface (i.e., opposite of recess 634) that is configured to facilitatecoupling of a distal core to the distal body 668. As shown, the proximalbody 664 is connected to the central body 662 by a bridge 502, while thedistal body 668 is connected to the central body 662 by a bridge 504.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 660 has a maximum about 0.125mm and about 0.400 mm, a maximum width between about 0.28 mm and about0.50 mm, and a length between about 0.16 mm and about 2.7 mm, with oneparticular embodiment having a maximum height of about 0.225 mm, amaximum width of about 0.295 mm, and a length of about 1.8 mm. Thesedimensions can be scaled up or down for larger or smaller diameter guidewires. Further, in the illustrated embodiment, the sides of the mountingstructure 660 have an overall rounded or arcuate profile (not shown, butsee examples with respect to mounting structures 300, 350, and 400above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 660 will be incorporated.

Referring now to FIG. 22, shown therein is a mounting structure 680according to another embodiment of the present disclosure. As shown,mounting structure 680 includes a body 682 having a proximal portion 684and a distal portion 686 with various structural features to facilitateinterfacing with other components of an intravascular device, such as aguide wire. For example, the body 682 includes recess 634 and opening638. The body 682 also includes a recess or opening 560 extending from abottom surface (i.e., opposite of recess 634) that is configured tofacilitate coupling of a core to the mounting structure 680. The distalportion of body 682 is configured to interface with components of thedistal tip of the guide wire, such as a distal core, distal coil, and/orother features.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 680 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 1.5 mm and about2.2 mm, with some particular embodiments having a maximum height ofabout 0.2 mm and a maximum width of about 0.295 mm. These dimensions canbe scaled up or down for larger or smaller diameter guide wires.Further, in the illustrated embodiment, the sides of the mountingstructure 680 have an overall rounded or arcuate profile (not shown, butsee examples with respect to mounting structures 300, 350, and 400above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 680 will be incorporated.

Referring now to FIG. 23, shown therein is a mounting structure 690according to another embodiment of the present disclosure. As shown,mounting structure 690 includes a body 692 having a proximal portion 694and a distal portion 696 with various structural features to facilitateinterfacing with other components of an intravascular device, such as aguide wire. For example, the body 692 includes recess 634 and opening638. The body 692 also includes a recess or opening 560 extending from abottom surface (i.e., opposite of recess 634) that is configured tofacilitate coupling of a core to the mounting structure 690. The distalportion 696 of body 692 includes a recess or opening 480 extending froma bottom surface (i.e., opposite of recess 634) that is configured tofacilitate coupling of a distal core to the body 692.

In some implementations for use within a guide wire having an outerdiameter of 0.014″, the mounting structure 690 has a maximum heightbetween about 0.125 mm and about 0.400 mm, a maximum width between about0.28 mm and about 0.50 mm, and a length between about 1.5 mm and about2.2 mm, with some particular embodiments having a maximum height ofabout 0.2 mm and a maximum width of about 0.295 mm. These dimensions canbe scaled up or down for larger or smaller diameter guide wires.Further, in the illustrated embodiment, the sides of the mountingstructure 690 have an overall rounded or arcuate profile (not shown, butsee examples with respect to mounting structures 300, 350, and 400above). In that regard, the radius or rate of curvature of therounded/arcuate sides is determined based on the desired outer diameter(e.g., 0.014″, 0.018″, etc.) of the guide wire into which the mountingstructure 690 will be incorporated.

Persons skilled in the art will also recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A sensing guide wire, comprising: a flexibleelongate member configured to be positioned within a blood vessel of apatient, the flexible elongate member comprising a proximal portion anda distal portion; a mounting structure disposed at the distal portion ofthe flexible elongate member, the mounting structure comprising a lengthalong a longitudinal axis, wherein the mounting structure comprises aplurality of material layers formed on top of one another, wherein twoor more of the plurality of material layers comprise a different widthin a direction perpendicular to the longitudinal axis, wherein thedifferent widths of the plurality of material layers together define asize and a shape of an outer profile of the mounting structure; and asensor mounted on the mounting structure, wherein the flexible elongatemember and the mounting structure each have an outer diameter of between0.0007″ and 0.118″.
 2. The sensing guide wire of claim 1, wherein thedifferent widths of the plurality of material layers together define arounded or arcuate shape.
 3. The sensing guide wire of claim 1, whereinadjacent material layers comprise the different widths such that theshape is defined in a step-wise manner.
 4. The sensing guide wire ofclaim 1, wherein each of the plurality of material layers comprises anupper surface and a lower surface parallel to the upper surface, andwherein each of the plurality of material layers has a constantthickness along the length.
 5. The sensing guide wire of claim 1,wherein each of the plurality of material layers has a same thickness.6. The sensing guide wire of claim 1, wherein the plurality of materiallayers comprises at least two layers.
 7. The sensing guide wire of claim1, wherein the plurality of material layers are each formed of a samematerial.
 8. The sensing guide wire of claim 1, wherein at least asubset of the plurality of material layers define a recess sized andshaped to receive the sensor.
 9. The sensing guide wire of claim 8,wherein the at least a subset of the plurality of material layers definethree wall portions partially surrounding the recess.
 10. The sensingguide wire of claim 1, wherein the mounting structure includes aproximal portion, a central portion, and a distal portion; wherein theproximal portion of the mounting structure is separated from the centralportion of the mounting structure by a proximal bridge comprising areduced outer profile diameter relative to the proximal and centralportions; and wherein the central portion of the mounting structure isseparated from the distal portion of the mounting structure by a distalbridge comprising a reduced outer profile diameter relative to thecentral and distal portions.
 11. The sensing guide wire of claim 1,wherein the mounting structure includes a first portion and secondportion spaced from the first portion by a bridge, wherein the bridgehas a reduced outer profile diameter relative to the first and secondportions.
 12. The sensing guide wire of claim 1, further comprising: adistal core wire extending within the flexible elongate member andfixedly attached to the mounting structure; and a proximal core wirefixedly attached to the mounting structure and extending proximally fromthe mounting structure, wherein the proximal core includes a firstsection that is fixedly attached to the mounting structure and a secondsection extending proximally from the first section, wherein the firstsection is formed of a first material and the second section is formedof a second material.
 13. The sensing guide wire claim 12, wherein thesecond material is different than the first material.
 14. The sensingguide wire of claim 12, wherein a distal end of the proximal core wireis positioned within an opening of the mounting structure and fixedlyattached to the mounting structure by solder.
 15. The sensing guide wireof claim 14, wherein the opening includes a first portion with a firstwidth and a second portion with a second width greater than the firstwidth, wherein the second portion is positioned distal of the firstportion.
 16. The sensing guide wire of claim 14, wherein the openingincludes a first portion and a second portion, the second portion offsetwith respect to the first portion relative to the longitudinal axis. 17.The sensing guide wire of claim 16, wherein the opening further includesa third portion aligned with the first portion relative to thelongitudinal axis, wherein the second portion is positioned between thefirst and third portions.
 18. The sensing guide wire of claim 12,wherein the proximal core wire further includes a third sectionextending proximally from the second section, wherein the third sectionis formed of a third material.
 19. The sensing guide wire of claim 18,wherein the third material is different than the second material. 20.The sensing guide wire of claim 1, further comprising: a conductorcomprising a proximal section and a distal section, wherein the distalsection of the conductor is coupled to the sensor and the proximalsection of the conductor is coupled to a connector at the proximalportion of the flexible elongate member.
 21. A guide wire, comprising: aflexible element; a core member extending within the flexible element; amounting structure fixedly secured to the core member, the mountingstructure comprising a plurality of material layers formed one on top ofanother, wherein each of the plurality of material layers comprises adifferent portion of a shape of the mounting structure and the pluralityof material layers together define a recess sized and shaped to receivea pressure sensing component, wherein each of the plurality of materiallayers comprises an upper surface and a lower surface parallel to theupper surface, wherein each of the plurality of material layers has aconstant thickness; the pressure sensing component mounted to themounting structure; and a conductor having a proximal section and adistal section, wherein the distal section of the conductor is coupledto the pressure sensing component and the proximal section of theconductor is coupled to a connector, wherein the flexible element andthe mounting structure each have an outer diameter of between 0.0007″and 0.118″.